Senior Scientist II-Cell, Process Development

Major responsibilities

• Develop UCAR-T platform across key unit operations (Tcell isolation/activation viral/nonviral gene delivery invitro expansion system harvest formulation and fill/finish) and build up representative small-scale model.
• Optimize process parameters and materials (activation condition electroporation setting media component feeding/control strategies) to improve process performance (knock-in/out efficiency viability expansion etc.) and product quality (viability purity etc.) and to ensure lot-to-lot consistency.
• Apply QbD during process development and optimization; implement PAT and statistical modeling (JMP) for parameter optimization process capability eveluation and build traceable data chains.
• Provide phaseappropriate process development and technical deliverables and support IIT adaptability INDa filing readiness latestage characterization and PPQ execution.
• Translate lab processes to clinicalgrade closed and automated systems; tech transfer process to clinical manufacturing.
• Draft technical documents including process development reports manufacturing batch record IND Module 3 and other related files; partner with Regulatory/Quality to ensure dossier completeness and review readiness.
• Ensure data authenticity and completeness related to the activities conducted.
• Complete other tasks assigned by the line manager.

Education Qualifications Skills and Experience

• Education:PhD or MSc in Cell Biology Immunology Molecular Biology Bioengineering Pharmacy or related field.
• Technical expertise: Hands-on experience in autologous and allogeneic CART process development and manufacturing; familiarity with UCART gene editing tools such as CRISPR/Cas9 based mutation.
• Process and equipment: Experience with closed and automated systems; familiarity with Xenon electroporation system Xuri W25/WAVE large-scale filling; proven labtoclinical scaleup and tech transfer.
• Data and modeling: Proficiency in statistical design/modeling (JMP) for parameter optimization process capability and consistency control.
• Collaboration: Experience in cross-function collaboration (MSAT QA/QC Manufacturing Regulatory Translational Medicine Clinical).
• Experience: Typically 2 years (PhD) or 5 years (MSc) in cell therapy or related biopharma; IND or BLA experience is a plus.
• Experience in UCAR-T full scale process platform is a plus.
• Basic English skills in reading and writing.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.